TY - JOUR T1 - Tiotropium + olodaterol fixed-dose combination shows clinically meaningful improvements in quality of life versus placebo JF - European Respiratory Journal JO - Eur Respir J DO - 10.1183/13993003.congress-2015.PA2958 VL - 46 IS - suppl 59 SP - PA2958 AU - Dave Singh AU - Gary T. Ferguson AU - Josef Bolitschek AU - Lars Grönke AU - Christoph Hallmann AU - Nathan Bennett AU - Roger Abrahams AU - Olaf Schmidt AU - Leif Bjermer Y1 - 2015/09/01 UR - http://erj.ersjournals.com/content/46/suppl_59/PA2958.abstract N2 - Introduction: Efficacy and safety of the fixed-dose combination (FDC) of tiotropium (T), a long-acting muscarinic antagonist, + olodaterol (O), a long-acting β2-agonist, has previously been established in pivotal Phase III studies in COPD. The present studies (OTEMTO 1 and 2) evaluated FEV1 and SGRQ score after 12 weeks of treatment with T+O FDC (2.5/5 µg; 5/5 µg) and T 5 µg compared to placebo (P) in patients with moderate to severe COPD.Methods: Two randomised, double-blind, parallel-group, Phase IIIb studies assessed the efficacy and safety of T 5 µg, T+O FDC 2.5/5 µg or 5/5 µg compared to P. Key inclusion criteria were age ≥40 years, diagnosis of COPD and post-bronchodilator FEV1 ≥30 and <80% predicted (GOLD 2–3).Results: 1621 patients were evaluated. Patient characteristics were similar between OTEMTO 1 and 2: mean post-bronchodilator FEV1 was 1.52 L and 1.55 L [55.3% and 54.8% predicted], respectively. Both studies met primary end points and significantly improved FEV1 AUC0–3, trough FEV1 and SGRQ with all treatments versus P (Table). There were no relevant safety findings.Conclusions: These studies show a consistent clinically meaningful improvement in SGRQ with T+O FDC 5/5 µg versus P, while confirming its effects on lung function parameters and safety.Funding: Boehringer Ingelheim. ER -